1. Field of the Invention
The present invention relates to processes for manufacturing sterile specimen containers. More specifically, the invention relates to a process for manufacturing specimen containers that incorporates a sterilisation stage, no longer requiring the outsourcing of sterilisation and costs associated therewith.
2. Description of the Prior Art
The medical industry utilises vast numbers of sterile specimen containers. The manufacturing process currently used to create these sterile containers lacks efficiency. This invention relates to the efficient production of sterile specimen containers.
Present sterile specimen container manufacturing processes lack an internal sterilisation step, and thus require added transportation, warehousing, and labour, as well as other logistical considerations to accommodate the outsourcing needed. Use of an outside firm to perform the sterilisation procedure increases the time and cost required to produce sterile specimen containers.
Commonly manufactured by thermoplastic and injection moulding systems, sterile specimen containers are fabricated in two separate parts. A thermoplastic polymer is used for the vial, while a thermoplastic resin is used for the cap. The current manufacturing practice involves separate moulding of vial and cap, at which point the two are separately cased and warehoused. When needed, the two components are pulled from storage, transported back to the plant, and loaded onto the capping line, where they are joined and proceed to be labelled, bagged, cased and returned to storage. Prom this warehousing juncture, the completed containers are shipped to a sterilisation facility for the final processing step of sterilisation. The sterile containers, in final product format, are shipped to the warehouse, after which point they are passed on to the distributor, followed by the end user.
The numerous warehousing terms required throughout the production lifecycle, along with the sterilisation procedure, constitutes a great portion of the total manufacturing time and cost. Further facilities for sterilizing items such as the containers discussed above are highly capital intensive and, therefore, only a few such facilities exist. As such, transport to and from these facilities poses various difficulties to a manufacturer. Thus, significant cost savings can be realized by avoiding the need for sterilizing containers at a different facility. These costs are generally attributable to labour, logistics, and overall supply chain management.
A production method which could be applied to eliminate the external outsourcing of sterilisation is proposed by Pike in U.S. Pat. No. 4,636,391. Pike teaches a process for creation of a thermoplastic film tube by extrusion. The tube itself is created at a sterilising temperature, 600 degrees Fahrenheit or greater, by the film extruder. The resultant sterile tube is kept within a sterile environment, until the point at which it is filled with a sterile product and sealed, preserving inner sterility. This reference teaches the employment of a sterilising process to eliminate the necessity of subsequent sterilisation steps. However, this reference does not suggest a method for producing sterile specimen containers or similar containers requiring sterile interiors.